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crea.lign Opaker 1

FDA UDI

Class II (US FDA UDI)

by bredent GmbH & Co. KG

Identity

Trade Name
crea.lign Opaker 1 FDA UDI
Generic Name
Dental veneer, professional FDA UDI
Device Name
crea.lign Opaker 1 A1/B2 4 g FDA UDI
Model / Reference
CLFHOP01 FDA UDI
Description
crea.lign Opaker 1 A1/B2 4 g FDA UDI

Identifiers

Catalog Number
CLFHOP01 FDA UDI
Primary DI / UDI-DI
EBRECLFHOP010 FDA UDI
FDA Product Code
EBF FDA UDI
GMDN Term
Dental veneer, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental veneer, professional

crea.lign Opaker 1 by bredent GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental veneer, professional.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
bredent GmbH & Co. KG

Sources (1)

  • FDA UDI a231096d-8eb5-4575-a28b-1d453b02dae0 35 fields · synced May 30, 2026